Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Overview

Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design

Full Title of Study: “Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2013

Interventions

  • Drug: Oral prednisolone
    • Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day

Arms, Groups and Cohorts

  • Experimental: High dose
    • Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
  • Active Comparator: Usual dose
    • Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
    • Time Frame: 14 days

Secondary Measures

  • Proportion of children with adverse effects
    • Time Frame: 14 days

Participating in This Clinical Trial

Inclusion Criteria

  • Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants Exclusion Criteria:
  • 1. Children with active systemic illness 2. Children with evidence of active tuberculosis 3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference < 11 cm/pedal edema/Weight for height < 3 SD) 4. Children with recurrent illness/chronic systemic illness

    Gender Eligibility: All

    Minimum Age: 3 Months

    Maximum Age: 24 Months

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Lady Hardinge Medical College
    • Provider of Information About this Clinical Study
      • Principal Investigator: Satinder Aneja, Director Professor – Lady Hardinge Medical College
    • Overall Official(s)
      • Satinder Aneja, MD, Principal Investigator, Lady Hardinge Medical College

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